BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTON DEAN DUAL 3000 ML. IRRIGATION PUMP

    MDR report key: 93224 · Received May 22, 1997

    Report

    Report Number
    9681384-1997-00057
    Event Type
    Injury
    Date Received
    May 22, 1997
    Date of Event
    March 20, 1997
    Report Date
    May 20, 1997
    Manufacturer
    ALTON DEAN MEDICAL, INC
    Product Code
    KQT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BLADDER PERFORATION OCCURRED DURING TURP, POSSIBLY DUE TO IRRIGATIN PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALTON DEAN DUAL 3000 ML. IRRIGATION PUMP SURGICAL IRRIGATION PUMP KQT ALTON DEAN MEDICAL, INC NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other